A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Metastatic Breast Cancer
In brief
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Key facts
- Study ID
- NCT04740918
- Run by
- Hoffmann-La Roche
- People needed
- 96
- Starts
- 2021-06-07
- Expected to finish
- 2024-06-19
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
- Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
- Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
- No more than two prior lines of therapy in the metastatic setting
- Measurable disease per RESIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy >= 6 months
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
You may not qualify if…
- Prior treatment with trastuzumab emtansine in metastatic setting
- History of exposure to cumulative doses of anthracyclines
- Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
- Current Grade >= 3 peripheral neuropathy
- Cardiopulmonary dysfunction
- History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- Active hepatitis B, hepatitis C and/or tuberculosis
- Prior allogeneic stem cell or solid organ transplantation
- Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
- Pregnancy or lactation
Where it is running
- Peter MacCallum Cancer Center — Melbourne, Victoria, Australia
- Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil
- Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda — Ijuí, Rio Grande do Sul, Brazil
- Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
- Núcleo de Pesquisa São Camilo — São Paulo, São Paulo, Brazil
- Royal Victoria Hospital — Barrie, Ontario, Canada
- Centre Hospitalier de l?Université de Montréal (CHUM) — Montreal, Quebec, Canada
- Peking University People's Hospital — Beijing, China
- Beijing Cancer Hospital — Beijing, China
- The First Hospital of Jilin University — Changchun, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China
- Zhejiang Provincial People's Hospital — Hangzhou, China
- Harbin Medical University Cancer Hospital — Harbin, China
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) — Nanjing, China
- Tianjin Medical University Cancer Institute & Hospital — Tianjing, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
- Henan Cancer Hospital — Zhengzhou, China
- Clinica Vida — Medellín, Colombia
- Oncomedica S.A. — Montería, Colombia
- Clinical Hospital Center Sestre Milosrdnice — Zagreb, Croatia
- Clinical Hospital Centre Zagreb — Zagreb, Croatia
- Helsinki University Central Hospital — Helsinki, Finland
- Tampere University Hospital — Tampere, Finland
- Emad Ibrahim, Md, Inc — Redlands, California, United States
Full record on ClinicalTrials.gov
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